The Effect of Yogurt Enriched With Flaxseed on Cardiovascular Risk Factors in Type 2 Diabetic Patients

The Effect of Yogurt Enriched With Flaxseed on Cardiovascular Risk Factors in Type 2 Diabetic

The investigators aimed to add flaxseed with high content of n-3 polyunsaturated fatty acids to low fat yogurt to obtain beneficial without adverse effects of it. In this parallel randomized controlled trial the investigators recruited 70 diabetic patients and randomly allocated to control and treatment groups. Participants in treatment group consumed 30 gr flaxseed in 200 gr low fat yogurt, while controls consumed 200 gr just low fat yogurt daily. Lipid profile, fasting blood sugar, glycosylated hemoglobin, systolic and diastolic blood pressure, weight, waist circumference and body mass index were measured at the first and end of the trial.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Dietary supplement: low fat yogurt enriched with flaxseed; Dietary supplement: low fat yogurt

Detailed Description

Nutritionists have concern about consumption of full fat dairy in diabetic patients due to their content of saturated fatty acids. The investigators aimed to add flaxseed with high content of n-3 polyunsaturated fatty acids to low fat yogurt to obtain beneficial without adverse effects of it. In this parallel randomized controlled trial the investigators recruited 70 diabetic patients and randomly allocated to control and treatment groups. Participants in treatment group consumed 30 gr flaxseed in 200 gr low fat yogurt, while controls consumed 200 gr just low fat yogurt daily. Lipid profile, fasting blood sugar, glycosylated hemoglobin, systolic and diastolic blood pressure, weight, waist circumference and body mass index were measured at the first and end of the trial.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• BMI between 20 and 35 kg/m2 -
• treated with oral hypoglycemic agents (Metformin or Glibenclamide)
• no use of insulin
• fasting blood glucose≥ 126 (but less than 400 mg/dl)or 2 hours blood sugar ≤ 200 mg/dl
• no pregnancy and lactation
• Blood lipids and blood pressure-lowering agents must remained unalteredwithin the last 3 months.

Exclusion Criteria:

• Participants were excluded if they smoked, used alcohol, took dietary supplements containing Omega 3, phytoestrogens, antioxidants and fiber regularly, had been diagnosed with GI disease or renal, liver, cancer , inflammatory disease, had food allergies or intolerances

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: low fat yogurt enriched with flaxseed; 200 gr low fat yogurt enriched with 30 gr flaxseed	Dietary supplement: low fat yogurt enriched with flaxseed; daily intake of low fat yogurt enriched with flaxseed for 8 weeks
Placebo Comparator: low fat yogurt; 200 gr low fat yogurt	Dietary supplement: low fat yogurt; daily intake of low fat yogurt for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in values of FBS at 8 week	FBS: Fasting blood sugar	8 weeks
Change from baseline in values of HbA1c at 8 week	HbA1C: glycosylated hemoglobin	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in values of weight at 8 week		8 weeks
Change from baseline in values of waist circumference at 8 week		8 weeks
Change from baseline in values of body mass index at 8 week		8 weeks
Change from baseline in values of blood pressure at 8 week	Blood pressure: systolic blood pressure, diastolic blood pressure	8 weeks
Change from baseline in values of Lipid profile (Total cholesterol, triglyceride, LDL-C, HDL-C) at 8 week	Lipid profile:Total cholesterol, triglyceride, LDL-C, HDL-C	8 weeks

Collaborators and Investigators

• Sponsor: Urmia University of Medical Sciences

Publications and helpful links

General Publications

• Hasaniani N, Rahimlou M, Ramezani Ahmadi A, Mehdizadeh Khalifani A, Alizadeh M. The Effect of Flaxseed Enriched Yogurt on the Glycemic Status and Cardiovascular Risk Factors in Patients with Type 2 Diabetes Mellitus: Randomized, Open-labeled, Controlled Study. Clin Nutr Res. 2019 Oct 2;8(4):284-295. doi: 10.7762/cnr.2019.8.4.284. eCollection 2019 Oct.

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: April 19, 2015
• First Submitted That Met QC Criteria: May 3, 2015
• First Posted (Estimate): May 6, 2015

Study Record Updates

• Last Update Posted (Estimate): May 6, 2015
• Last Update Submitted That Met QC Criteria: May 3, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: flaxseed; lipid profile; diabetic patients; cardiovascular risc factors
• Other Study ID Numbers: umsu.rec.1393.3